MAUDE Adverse Event Report: IRHYTHM TECHNOLOGIES, INC ZIO XT PATCH; ZIO PATCH

Model Number N100A102X

Device Problem Patient Data Problem (3197)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2021

Event Type  malfunction  

Manufacturer Narrative

At the conclusion of the investigation, it was determined that the cause of the incorrect report provided to the healthcare provider was due to a registration error that occurred when the healthcare provider swapped the registration of two devices due to user error.Irhythm then provided the reports to the healthcare provider based on the registration information provided.The healthcare provider reported to irhythm that one patient was implanted with a pacemaker.The report provided does not provide diagnosis; rather it provides preliminary findings from which the clinician may make a diagnosis based on clinical judgement and patient clinical history.

Event Description

A final ecg report was provided to the physician with incorrect patient information provided by the healthcare provider.As a result, the wrong patient was treated.

• Brand Name: ZIO XT PATCH
• Type of Device: ZIO PATCH
• Manufacturer (Section D): IRHYTHM TECHNOLOGIES, INC; 699 8th st; suite 600; san francisco CA 94103
• Manufacturer (Section G): IRHYTHM TECH, INC; 11085 knott avenue; suite b; cypress CA 90630
• Manufacturer Contact: mazi kiani ; 699 8th st; suite 600; san francisco, CA 94103 ; 9494132147
• MDR Report Key: 11314962
• MDR Text Key: 232622102
• Report Number: 3007208829-2021-00013
• Device Sequence Number: 1
• Product Code: DSH
• UDI-Device Identifier: 00869770000203
• UDI-Public: 00869770000203
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/08/2021
• Device Model Number: N100A102X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR